CLINICAL TRIALS PROFILE FOR LITHIUM CARBONATE

All Clinical Trials for LITHIUM CARBONATE

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00057681 ↗	Study of Outcome and Safety of Lithium, Divalproex and Risperidone for Mania in Children and Adolescents	Completed	National Institute of Mental Health (NIMH)	Phase 3	2003-02-01	This study will evaluate the effectiveness of the medications, lithium (Eskalith®), valproate (Depakote®), and risperidone (Risperdal®) in treating children and adolescents with bipolar disorder or symptoms of mania.
NCT00057681 ↗	Study of Outcome and Safety of Lithium, Divalproex and Risperidone for Mania in Children and Adolescents	Completed	Washington University School of Medicine	Phase 3	2003-02-01	This study will evaluate the effectiveness of the medications, lithium (Eskalith®), valproate (Depakote®), and risperidone (Risperdal®) in treating children and adolescents with bipolar disorder or symptoms of mania.
NCT00000439 ↗	Drug Treatment for Alcoholics With Bipolar Disorder	Completed	University of Pittsburgh	Phase 2	2000-10-01	The purpose of this study is to test the effectiveness of sodium valproate (Depacon) in treating individuals with alcohol dependence and comorbid bipolar disorder.
NCT00000439 ↗	Drug Treatment for Alcoholics With Bipolar Disorder	Completed	National Institute on Alcohol Abuse and Alcoholism (NIAAA)	Phase 2	2000-10-01	The purpose of this study is to test the effectiveness of sodium valproate (Depacon) in treating individuals with alcohol dependence and comorbid bipolar disorder.
NCT00000369 ↗	Maintenance Therapies in Bipolar Disorders	Completed	University of Pittsburgh	Phase 3	1997-06-01	The purpose of this study is to see if adding a regimen of individualized psychotherapy can help bipolar I patients who are on lithium. While having a manic or depressed episode patients will be assigned randomly (like tossing a coin) to receive appropriate medication either with or without additional individual psychotherapy. If a patient responds well, he/she will again be assigned randomly to receive further preventative treatment in which medication will be managed either with continued medication clinic visits alone or with additional individual psychotherapy (the patient may not receive the same additional treatment this time). Patient response to treatment will be evaluated throughout the study. If manic/depressive symptoms return at any point during the study, the patient will be treated with appropriate medication and will continue the study. An individual may be eligible for this study if he/she: Has Bipolar I disorder, is experiencing a manic or depressed episode at the time of study entry, and is at least 18 years old.
NCT00005015 ↗	Treatment of Depression in Youth With Bipolar Disorders	Terminated	National Institute of Mental Health (NIMH)	Phase 3	1969-12-31	THIS STUDY HAS BEEN DISCONTINUED. The study is designed to evaluate the safety and efficacy of fluoxetine for treating children and adolescents with Bipolar Disorder who are experiencing an episode of major depression while being treated with a mood stabilizer. The study involves a 2-week assessment period. Patients who are on stable, therapeutic doses of lithium or valproate and continue to have depression will be randomized to a 12-week treatment of fluoxetine or placebo. Those who respond favorably to treatment will be followed openly for an 18-week continuation phase.

Clinical Trial Conditions for LITHIUM CARBONATE

Condition Name

Condition Name for LITHIUM CARBONATE
Intervention	Trials
Bipolar Disorder	26
Depression	7
Major Depressive Disorder	7
Spinal Cord Injuries	5

Condition MeSH

Condition MeSH for LITHIUM CARBONATE
Intervention	Trials
Bipolar Disorder	35
Disease	17
Depression	17
Depressive Disorder	15

Clinical Trial Locations for LITHIUM CARBONATE

Trials by Country

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Trials by Country for LITHIUM CARBONATE
Location	Trials
United States	104
China	18
Canada	17
Italy	8
Australia	6

Trials by US State

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Trials by US State for LITHIUM CARBONATE
Location	Trials
Pennsylvania	13
New York	10
Ohio	10
California	8
Texas	7

Clinical Trial Progress for LITHIUM CARBONATE

Clinical Trial Phase

Clinical Trial Phase for LITHIUM CARBONATE
Clinical Trial Phase	Trials
Phase 4	24
Phase 3	16
Phase 2/Phase 3	3

Clinical Trial Status

Clinical Trial Status for LITHIUM CARBONATE
Clinical Trial Phase	Trials
Completed	60
Recruiting	11
Terminated	11

Clinical Trial Sponsors for LITHIUM CARBONATE

Sponsor Name

Sponsor Name for LITHIUM CARBONATE
Sponsor	Trials
National Institute of Mental Health (NIMH)	14
China Spinal Cord Injury Network	5
Roxane Laboratories	4

Sponsor Type

Sponsor Type for LITHIUM CARBONATE
Sponsor	Trials
Other	129
NIH	29
Industry	17

Lithium Carbonate: Clinical Trials, Market Analysis, and Projections

Introduction to Lithium Carbonate

Lithium carbonate is a versatile compound with significant applications in both pharmaceutical and industrial sectors. In the pharmaceutical arena, it is widely used as a mood stabilizer for treating mental health conditions such as bipolar disorder, major depressive disorder, and post-traumatic stress disorder. Here, we will delve into the current state of clinical trials, market analysis, and future projections for lithium carbonate.

Clinical Trials Update

AL001 (LISPRO®) by Alzamend Neuro

Alzamend Neuro is advancing a novel formulation of lithium carbonate, known as AL001 or LISPRO®, which is an ionic cocrystal of lithium. This formulation is being developed for the treatment of Alzheimer’s disease, bipolar disorder, major depressive disorder, and post-traumatic stress disorder. The first-in-human Phase I clinical trial commenced in September 2021, and the topline data indicated that AL001 at a 150 mg dosage is bioequivalent to the marketed 300 mg lithium carbonate product. The safety profiles of both AL001 and the marketed lithium carbonate were found to be benign. A Phase II multiple-ascending dose study in Alzheimer’s patients was completed in March 2023, with topline data expected in June 2023. Phase II clinical studies for bipolar disorder, major depressive disorder, and post-traumatic stress disorder are anticipated to begin in 2025[1].

PRELUDE Clinical Trial for Motor Neuron Disease (MND)

The PRELUDE clinical trial is a major international, multi-centre, Phase III trial investigating the effect of lithium carbonate on survival in people living with MND who have a specific gene mutation (UNC13a). Although previous trials did not show significant benefits, recent analyses suggest potential benefits for individuals with this gene mutation. This trial is part of the MAGNET platform trial, which aims to find effective treatments for MND by testing multiple treatments simultaneously[4].

Market Analysis

Pharmaceutical Grade Lithium Carbonate Market

The global pharmaceutical grade lithium carbonate market was valued at USD 141 million in 2023 and is projected to reach USD 166 million by 2028, growing at a CAGR of 3.3%. The market is driven by the increasing number of mental health conditions, growing awareness of mental health, and changes in lifestyle and stress. Extended release formulations dominate the market due to their convenience and higher patient compliance[3].

Industrial and Battery-Grade Lithium Carbonate Market

The lithium carbonate market, including both battery-grade and industrial applications, was valued at USD 8.81 billion in 2023 and is expected to reach USD 10.03 billion in 2024. It is projected to grow at a CAGR of 14.33% to USD 22.50 billion by 2030. This growth is fueled by the rising demand for lithium-ion batteries in consumer electronics, automotive, and energy storage systems, as well as the global shift towards sustainable energy sources[5].

Market Projections

Price Trends

The lithium carbonate market is expected to face a global surplus in 2025, leading to a decline in prices. The annual average price for lithium carbonate is projected to drop to around $10,542/mt in 2025, down from $12,374/mt in 2024 and significantly lower than the 2023 average of $40,579/mt. This surplus is expected to narrow significantly through 2027 due to upcoming lithium supply cuts[2].

Growth Drivers

• Rising Demand for Lithium-Ion Batteries: The increasing adoption of electric vehicles and renewable energy solutions is driving the demand for lithium-ion batteries, which in turn fuels the need for lithium carbonate[5].
• Growing Awareness of Mental Health: The increasing awareness and diagnosis of mental health conditions are driving the demand for pharmaceutical grade lithium carbonate[3].
• Advancements in Battery Technologies: Continuous innovations in battery technologies are enhancing the efficiency and demand for lithium carbonate[5].

Challenges

• Stringent Regulatory Standards: The pharmaceutical grade lithium carbonate market faces stringent regulatory standards, including extensive clinical trials and safety evaluations, which can be costly and time-consuming[3].
• Fluctuating Lithium Prices: The market is vulnerable to fluctuating lithium prices, which can impact production costs and profitability[5].
• Environmental Concerns: Lithium mining and extraction processes raise environmental concerns, which can affect market growth and public perception[5].

Regional Market Insights

Pharmaceutical Grade Lithium Carbonate

North America is projected to account for the largest market share in the pharmaceutical grade lithium carbonate market due to the presence of leading research institutions, government policies promoting mental health care, and high diagnostic rates of mental illnesses[3].

Industrial and Battery-Grade Lithium Carbonate

The global market for industrial and battery-grade lithium carbonate is distributed across various regions, with significant players operating in Asia, North America, and Europe. The market is influenced by regional demand for lithium-ion batteries and other industrial applications[5].

Key Takeaways

• Clinical Trials: Novel formulations like AL001 and ongoing trials like PRELUDE are expanding the therapeutic potential of lithium carbonate.
• Market Growth: The pharmaceutical grade lithium carbonate market is expected to grow at a CAGR of 3.3% from 2023 to 2028, while the industrial and battery-grade market is projected to grow at a CAGR of 14.33% from 2023 to 2030.
• Price Trends: Lithium carbonate prices are expected to decline in 2025 due to a global surplus.
• Growth Drivers: Rising demand for lithium-ion batteries and growing awareness of mental health are key drivers.
• Challenges: Stringent regulatory standards, fluctuating prices, and environmental concerns pose significant challenges.

FAQs

What are the current clinical trials involving lithium carbonate?

Current clinical trials include the Phase II studies for AL001 by Alzamend Neuro for Alzheimer’s disease, bipolar disorder, major depressive disorder, and post-traumatic stress disorder, as well as the PRELUDE trial for Motor Neuron Disease (MND)[1][4].

How is the market for pharmaceutical grade lithium carbonate expected to grow?

The market is projected to grow at a CAGR of 3.3% from 2023 to 2028, reaching USD 166 million by 2028[3].

What are the main drivers of the lithium carbonate market?

The main drivers include the rising demand for lithium-ion batteries, growing awareness of mental health, and advancements in battery technologies[3][5].

What challenges does the lithium carbonate market face?

The market faces challenges such as stringent regulatory standards, fluctuating lithium prices, and environmental concerns related to mining operations[3][5].

How are lithium carbonate prices expected to change in 2025?

Lithium carbonate prices are expected to decline in 2025 due to a projected global surplus, with the annual average price dropping to around $10,542/mt[2].

Sources

1. Alzamend Neuro: Product Pipeline - Alzamend Neuro
2. S&P Global Commodity Insights: COMMODITIES 2025: Global surplus, declining prices weigh on Europe's lithium ambitions
3. MarketsandMarkets: Pharmaceutical Grade Lithium Carbonate Market
4. MND Association: PRELUDE Clinical Trial
5. GII Research: Lithium Carbonate Market by Grade, Purity, Application